Composition for diagnosing the transport function of the fallopian tube and a method for preparing said composition

Abstract

The present invention pertains to a preparation for diagnosing the transport function of the fallopian tube and to a method for making such a preparation. The diagnostic preparation for investigation of the transport function of female fallopian tube, comprises a suspension of a biocompatible, biodegradable, and, if desired, labelled particles, in a vehicle commonly used for parenteral applications wherein the particles have a spherical shape with diameters in the region 10 to 600 um, which are formed from a soft hydrophilic gel based on a polymer selected from the group comprising additionally crosslinked water-soluble nontoxic and biodegradable inert polysaccharides and physiologically inert water-soluble and biodegradable poly(amino acids), polypeptides, and their derivatives, which may contain physiologically active substances. The particles retain their shape and size in the environment of peritoneal cavity and uterotubal tract for at least 80 hours with the subsequent degradation to nontoxic product within 5 to 60 days. A method for preparation of the diagnostic preparation comprises dispersing an aqueous solution of physilogically inert, biodegradable polymer selected from the group of polysaccharides, poly(amino acids), polypeptides, and their derivatives, in a medium of nonpolar water-immiscible solvent, to 10 wt. % of the polymer having a degree of polymerization of 50 to 500, said suspension containing of 80 to 100 mol. % of gamma -alkyl-L-glutamate units and 0 to 20 mol. % units of L-glutamic acid, units as a suspension stabilizer, with mixing sufficient to form polymeric spherical particles with diameter 100 to 600 um, which are transferred into the gel state with bifunctional crosslinking agents. The particles are washed and then dispersed in an aqueous solution. The resulting suspension is then sterilized by heat.

We claim: 
     
       1. A diagnostic preparation for use in investigation of the transport function of a female fallopian tube, comprising a suspension of particles in a vehicle, wherein said particles (1) have a spherical shape with a diameter from about 10 to about 600 um, (2) are formed from a soft hydrophilic gel based on a crosslinked, nontoxic, biodegradable polymer selected from (a) polysaccharides which contain glucose bound predominantly throughb 1,4 glycoside bonds, (b) polyamino acids derived from glutamic acid or aspartic acid, and (c) polypeptides which are soluble derivatives of collagen or elastin, and (3) retain their shape and size in the environment of a peritoneal cavity and a uterotubal tract for at least 80 hours and subsequently degrade to nontoxic products within 5 to 60 days in such an environment, and   said vehicle is a physiologically acceptable vehicle suitable for parenteral injection.   
     
     
       2. The preparation of claim 1 wherein the biodegradable polymer is a polysaccharide. 
     
     
       3. The preparation of claim 1 wherein the biodegradable polymer is a poly(amino acid) or a polypeptide. 
     
     
       4. The preparation of claim 1 wherein the particles have a chromophoric or fluorophoric compound convalently bound to the polymeric compound of the particles. 
     
     
       5. The preparation of claim 1 wherein an additional substance which influrences a biological property is bonded to the particles, said substance being selected from the group consisting of poly(amino acids), polypeptides, and hormones. 
     
     
       6. A method for the preparation of a diagnostic preparation for use in investigation of the transport function of a female fallopian tube, comprising dispersing, in a nonpolar, water-immiscible solvent, an aqueous suspension of a nontoxic, biodegradable polymer selected from (a) polysaccharides which contain glucose bound predominantly throughb 1,4 glycoside bonds, (b) polyamino acids derived from glutamic acid or aspartic acid, and (c) polypeptids which are soluble derivatives of collagen or elastin, said nonpolar, water-immiscible solvent containing from 0.1 to 10 wt. % of a polymeric suspension stabilizer, said dispersing being with mixing sufficient to form polymeric spherical particles having diameters from 10 to 600 um, transforming the particles into a gel state by contacting the same with a bifunctional crosslinking agent, washing the same with an alkaline aqueous solution, and dispersing the particles in a vehicle which is suitable for parenteral administration. 
     
     
       7. The method of claim 6 wherein the suspension stabilizer contains 80-100 mol. % of gamma-alkyl-L-glutamate units and 0-20 mol. % of L-glutamic acid. 
     
     
       8. The method of claim 6 further comprising the step of chemically activating the particles for binding with biologically active peptides. 
     
     
       9. The method of claim 6 wherein the aqueous suspension also contains an aminoacyl derivative of a fluorochrome, a dispersed pigment, or magnetic particles, in an amount from 0 to about 10 wt. %.